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# Merck sBLA Accepted for Keytruda in Bladder Cancer
- URL: https://www.fdaweb.com/merck-sbla-accepted-for-keytruda-in-bladder-cancer/
- Published: 2019-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:54:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145624

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy as monotherapy for treating patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). The submission is based on data from the Phase 2 KEYNOTE-057 trial, which will be discussed at a 12/17 meeting of FDA’s Oncologic Drugs Advisory Committee. Merck says it expects FDA will set a 1/2020 user fee review target action date.